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FDA Finds Flaws In Theranos' Zika Tests (techcrunch.com) 74

An anonymous reader quotes a report from TechCrunch: This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn't welcome to provide it yet is Theranos. The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports (Warning: may be paywalled). Specifically, regulators found that in developing and testing a new Zika-diagnostic technology, Theranos failed to use proper patient safety protocols, the type approved by an institutional review board. Such protocols are critical in ensuring the ethical treatment of patients involved in studies, and their safety. Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.
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FDA Finds Flaws In Theranos' Zika Tests

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  • Girl Power! (Score:5, Insightful)

    by alternative_right ( 4678499 ) on Wednesday August 31, 2016 @04:34PM (#52804985) Homepage Journal

    How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?

    How much actually focused on the product and the likelihood of it succeeding?

    Our news today is more entertainment than fact.

    • by msauve ( 701917 )
      How can the FDA find ethical or safety issues in running tests on a vial of blood, or even poking someone who agrees with a lancet? Really, I got poked with a lancet in middle school biology class, and I'm sure the teacher didn't have to go through any damn review board.
    • by mADneSs ( 167736 )

      How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?

      In that vein, how much of the hate is centered on the same thing? Certainly less, I'm sure, but I'd wager you wouldn't see the same amount of vitriol if Theranos was helmed by some random CEO Joe. Unless it were Martin Shkreli, perhaps ... but that's a whole different sack of assholes.

      • Re: (Score:2, Funny)

        by Anonymous Coward

        So you pre-emptively void a counter-example to establish an ad hoc save of your grouping statement?

        There's a phrase for that.

      • In the industry, a lot of the hate came from the "Andy Grove Fallacy" scientific approach first , the hate for the "do first, ask foregiveness later" business model came later.

        http://blogs.sciencemag.org/pipeline/archives/2007/11/06/andy_grove_rich_famous_smart_and_wrong

        Software and hardware design always proceeds from highly predictable and well documented systems. Most things can be simulated from first principles, and unpredictable pieces of hardware are eliminated, either at the design stage or repla

        • Most things can be simulated from first principles, and unpredictable pieces of hardware are eliminated, either at the design stage or replaced in the field as they fail. Biology is the opposite: simulations are empirical and only work at the level of complexity where the fudge factors have been applied.

          Insightful. I see this division all the time: some fields succumb to theory; others require a consequentialist outlook.

    • Because companies run by male CEOs never have ethical problems. No sirreee, we must look at companies run by women, their gender makes them suspect!

      • Sorry, but when you wave the pussy pass to get your company noticed in the first place, it will be mentioned when you are discovered to be a fraud.
    • Re:Girl Power! (Score:4, Informative)

      by Razed By TV ( 730353 ) on Wednesday August 31, 2016 @05:39PM (#52805277)

      How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?

      I would say not much. Theranos was promising drug tests that would be significantly cheaper than current tests. According to Theranos pricing, Basic Metabolic Panel for about $6 bucks, Lithium level for $5... Together those might cost $200 (without insurance). I couldn't give two shits about who is at the helm if that's what they're promising.

      • by pla ( 258480 )
        I couldn't give two shits about who is at the helm if that's what they're promising.

        Do you care about accuracy? Because Theranos apparently doesn't and just makes shit up wholesale.

        So if not - Let me save you hundreds or even thousands of dollars, and a painful blood draw! Just send me a dollar, the test you want, and your return address, and I'll send you back a random number for whatever test you've requested! Win-win, if price counts as your only consideration!
        • I think we're all well aware at this point that Teranos did not have a legitimate service. My point was simply that Theranos's claim of a groundbreaking technique was much more of a draw than seeing an attractive female CEO.
          • My point was simply that Theranos's claim of a groundbreaking technique was much more of a draw than seeing an attractive female CEO.

            This was accepted because the attractive girl fits into one of our media tropes, the Girl Power! trope. It also fits into our Silicon Valley trope.

            These tropes encourage us to believe that the unlikely is possible because that's the way it happens in movies. If Theranos had been helmed by an old white guy, there would have been media pushback, critical questions, etc.

            Instead t

        • Do you care about accuracy?

          Neither do venture capitalists! They seem to reckon everyone lies (they don't) and they they are smart enough to know by how much (they aren't). Their idea of due dilligence seems to be 6 months of arsing around followed by checking to see if anyone else has invested then joining the dogpile.

          Oh an the dogpile is big because no one wants to lose face by not investing in the big winner that all their frenemies invested in.

      • Hype (as in money) was also generated by filling the board with smart, serious, famous people who knew absolutely nothing about any of the technical or medical problems but were only there for influence. Henry Kissinger? George Schultz? Navy admirals and Marine generals??
    • Re:Girl Power! (Score:4, Insightful)

      by f97tosc ( 578893 ) on Wednesday August 31, 2016 @06:59PM (#52805665)

      How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?

      How much actually focused on the product and the likelihood of it succeeding?

      Our news today is more entertainment than fact.

      Well at this point the primary story is the meta story about how otherwise sophisticated investors put in tons of money behind the the young, attractive, blonde woman even though they were shown very little evidence. That meta story is both entertaining and fact based.

      • Well at this point the primary story is the meta story about how otherwise sophisticated investors put in tons of money behind the the young, attractive, blonde woman even though they were shown very little evidence. That meta story is both entertaining and fact based.

        The thing is with playing up the young, blonde part... where are all the stories about VCs putting vast amounts of money behind ordinary looking guys (as happens a lot) and losing it all because it was always a really stupid idea. The "young,

    • How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?

      Don't knock blondes, it's just everyone from Stanford that is a shiesty scammer with no morals or competence.

    • Eh...you left out the part about her deciding, after one year at college, that the whole education thing was overrated and she should just go ahead and found Theranos. Despite not having any background in medicine, chemistry or biology.

      Too "smart" for her own good.

    • Holmes had indeed mastered the Silicon Valley game. Revered venture capitalists, such as Tim Draper and Steve Jurvetson, invested in her; Marc Andreessen called her the next Steve Jobs. She was plastered on the covers of magazines, featured on TV shows, and offered keynote-speaker slots at tech conferences. (Holmes spoke at Vanity Fair’s 2015 New Establishment Summit less than two weeks before Carreyrou’s first story appeared in the Journal.) In some ways, the near-universal adoration of Holmes

  • by NoNeeeed ( 157503 ) <(slash) (at) (paulleader.co.uk)> on Wednesday August 31, 2016 @04:36PM (#52804991)

    ...before you get the idea that you need to start doing things properly?

    Theranos really don't seem to be getting the hint that if they want to be taken seriously now they need to be utterly scrupulous about everything they do.

    • Re: (Score:3, Insightful)

      by Anonymous Coward

      How many times does a company like this need to screw up before being forcibly shut down by the feds?

      Embezzle a little money and they come in and lock the doors on any business you run. Endanger people's lives and you get a slap on the wrist. What's wrong with this picture?

      captcha = "boners"

      • by TroII ( 4484479 )

        How many times does a company like this need to screw up before being forcibly shut down by the feds?

        If the CEO was a man instead of the poster child for "women STEM CEOs," it would have been shut down a long time ago.

    • Hey, it's a startup, aren't you supposed to run fast, break things, fail fast? Fix it in the next release!
  • by JoeyRox ( 2711699 ) on Wednesday August 31, 2016 @04:42PM (#52805021)
    She's like an 8 year old playing doctor at the playground. She has unbridled enthusiasm, uses lots of big words that she overheard adults using, and pushes all the other kids who make fun of her for pretending to be something she's not.
    • by Anonymous Coward

      I wonder how much longer it will take before people finally realize Theranos and Holmes are a scam.

  • by Anonymous Coward

    FDA Finds Flaws In Theranos' Zika Tests

    Nope. The FDA didn't find a thing wrong with the actual test.

    The FDA found flaws in the process used to validate the test, and more specifically around the patient data privacy.

    That has nothing to do with a judgement that the underlying test isn't effective.

    • by Qzukk ( 229616 )

      If the validation was done wrong, then the test isn't valid until the validation is done right.

      If the validation was done right but the patients' privacy was breached, fine them under HIPAA and if the company isn't bankrupt, let them do their testing.

      • by imidan ( 559239 ) on Wednesday August 31, 2016 @05:27PM (#52805219)
        The accusation isn't that patients' privacy was violated. The issue is that there should have been an Institutional Review Board that reviewed the researchers' protocols and plans for interacting with subjects and handling samples to ensure that subjects were treated ethically and safely (among other things). And there was, at least for some parts of the research, but not for all of it. According to them, the part that didn't go through review was lab work that didn't involve any interaction with the subjects. So while these safety and ethics issues are very important with medical research, at the moment there's no indication of a major problem with Theranos' approach. They'll likely need to perform another IRB review, making sure to include every part of the research, and making sure it's super thorough. As long as their method works, I would hope that a new IRB review would satisfy regulators.
        • If their method works, but they violated the patient protocol, easy peasy. TAKE their approach, TAKE their capital (money and equipment) and tell their entire management staff they are out of biz, and further they are banned from any medical company for life. Now that would be incentive in the future for all medical companies to follow patient protocol.

    • "The scientific method is stupid!" You heard it here first!
  • by Wrath0fb0b ( 302444 ) on Wednesday August 31, 2016 @04:50PM (#52805053)

    ... but the FDA is still finding something to complain about.

    This is after preeminent scientists argue that bioethics needs to get out of the way [bostonglobe.com] of modern research.

    An interesting parallel, by the way, was John Nestor. Here was a guy that intentionally (and even with good intention) drove 55MPH in the fast lane of DC traffic [washingtonpost.com]. He was, at best, misguided, since speed differential is more dangeous than speed [wikipedia.org] and his actions were likely safety-reducing. He was also an FDA bureaucrat that never approved a drug and was ultimately fired [jpands.org] for his "caution" that probably cost more lives and more lifesaving drugs than it ever saved.

    • by tomhath ( 637240 ) on Wednesday August 31, 2016 @05:11PM (#52805135)
      If the company had adhered to the FDA's rules from the beginning instead of doing everything they could to cut corners, deceive investors, and generally act like the law doesn't apply to them the FDA might have cut them some slack this time. But they poisoned that relationship. Now the FDA is going to make them follow the letter of the law, every time, no exceptions.
    • by umafuckit ( 2980809 ) on Wednesday August 31, 2016 @05:19PM (#52805189)

      ... but the FDA is still finding something to complain about.

      I can't see it say anywhere that the diagnostic test from Theranos works. It just says that there are problems with associated protocols. Seems like yet another example of their corner cutting behavior. Theranos doesn't exactly have a good history of producing reliable diagnostic tests.

    • There is plenty of room for the FDA to ease up on experimental medicine, but I've got to assume you're either a very competent troll or a marketing shill. Theranos doesn't do anything new, they in fact pretend to do the same thing as everyone else cheaper, while not doing it at all. They are marketing people who decided their next scam should be in healthcare, aka: the ultimate scum of Humanity.
      • What the FDA really needs to do is ease up on "me-too" products. The latest drug price scandals were not a result of drug patents, but because getting permission to sell something like an Epi-Pen takes a long time and is expensive. So, drug company A produces something, realizes it's got a monopoly, and raises the price a lot. Drug company B can take a year or three and spend lots of money and get permission to produce the same thing, and drug company A then drops the price to previous levels to hurt dr

        • That's not the case here. Plenty of people (pretty much everyone) got approved for Zika blood testing. Theranos didn't get approved because they are scammers.
    • There is no such thing as a "fast" lane in the United States. Calling it such is part of the problem. There are "travel" lanes and "passing" lanes (and in some cases slow-vehicle lanes for steep grades). It's not a "left" lane. It's not a "fast" lane. They are "passing" lanes.

      Also, I think it was Abraham Lincoln who said(?) "The best way to get rid of an unjust law is to enforce it strictly."

      Forcing others to abide by an unjust law as a form of civil disobedience in an attempt to get the law repealed is
  • by Anonymous Coward

    She started off iam sure with good intentions until she discovered it (their magic machine "Edison") doesnt actually work, by then she had enough funding to make her rich for life, she couldn't just stop and say sorry it doesn't work and hand the money back to investors she would be ruined, now she is in too deep to stop and so the charade continues until she is forced to stop.
    shame peoples lives are at risk while it continues, much like Teslas "autopilot", how many innocent people have to die until you cal

  • by Anonymous Coward

    I thought Theranos had been banned form blood work. Why are they still in operation?

    • by tomhath ( 637240 )
      She's banned from operating a lab. They're trying to get around that by selling devices instead operating them.
    • Re: (Score:2, Funny)

      by Anonymous Coward
      They really should get back in their lane and stick to selling bottles that keep hot things hot and cold things cold, imo
  • There's nothing about the test being wrong. It' just that they ignored patient safety while conducting trials.

    If you don't read the article, please don't write the headline.

  • by Anonymous Coward

    These people are trying to run big pharm like it's a startup selling kitten mittens. Do it fast, get it to the market without proper testing and let our users beta test. It's all an internet scam, the only difference between Theranos and some other dot com blowout, is the government has more control over approval for medical treatments and devices.

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